Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

Eligibility

Inclusion Criteria:

* Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
* At least one measurable untreated lesion
* Intrahepatic tumors can be treated with 1-2 session of SIRT
* Child-Pugh score 5-7
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Life expectancy of at least 3 months
* Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
* Patients with hepatitis C need to finish the anti-HCV treatment

Exclusion Criteria:

* tumor extent ≥70% liver occupation
* Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
* Vena cava invasion
* Central nervous system metastasis
* Metastatic disease that involves major airways or blood vessels
* Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
* History of organ and cell transplantation
* Prior esophageal and/or gastric varices bleeding
* History of hepatic encephalopathy
* Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L
* Prolongation of prothrombin time ≥ 4 seconds
* Severe organ dysfunction (heart, lungs, kidneys)
* History of malignancy other than HCC
* HBsAg and anti-HCV antibody positive concurrently
* Human immunodeficiency virus (HIV) infected

Conditions4

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